Metformin ER 500mg Modified Tabs

Metformin is a biguanide that improves glucose tolerance in patients with type 2 diabetes by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization. It does not stimulate insulin secretion and, therefore, does not cause hypoglycemia in monotherapy.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat

Additionally, if you experience stomach problems later during treatment, such as upset stomach, vomiting, or diarrhea, contact your doctor right away, as this may be a sign of lactic acidosis, a serious condition affecting the blood's acid balance.

Low Blood Sugar: A Potential Risk

Low blood sugar can occur, especially when this medication is used with other diabetes treatments. Be aware of the following signs of low blood sugar:

Dizziness
Headache
Feeling sleepy or weak
Shaking
Fast heartbeat
Confusion
Hunger
Sweating

If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Stomach pain or heartburn
Gas
Diarrhea, upset stomach, or vomiting
Feeling tired or weak
Headache

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Acidic blood problems
+ Kidney disease
+ Liver disease
Recent medical events, such as a heart attack or stroke
Any difficulties with eating or drinking, including situations where you may be required to fast before a procedure or surgery
* Upcoming or recent exams or tests that involve contrast agents, particularly if they have taken place within the past 48 hours

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before consuming alcohol, discuss the potential risks with your doctor.

If you experience low blood sugar, do not operate a vehicle, as this can increase your risk of being involved in an accident. Monitor your blood sugar levels as directed by your doctor, and undergo blood tests as scheduled to ensure your condition is being properly managed. Discuss any concerns or questions with your doctor.

During periods of stress, such as illness, infection, injury, or surgery, your blood sugar levels may be more challenging to control. Changes in physical activity, exercise, or diet can also impact your blood sugar levels. Adhere to the diet and exercise plan recommended by your doctor to maintain optimal control.

If you experience diarrhea or vomiting, contact your doctor promptly, as you may need to increase your fluid intake to prevent excessive fluid loss. In hot weather or during intense physical activity, be cautious and drink plenty of fluids to avoid dehydration.

Long-term treatment with metformin may lead to a decrease in vitamin B-12 levels. If you have a history of low vitamin B-12 levels, consult with your doctor. You may notice the appearance of the tablet in your stool, but this is a normal occurrence and not a cause for concern. If you have any questions or concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age who have not been ovulating may experience a renewed risk of pregnancy while taking this medication. To avoid pregnancy, use birth control measures while taking this drug.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby.

• Iodinated contrast media (hold metformin before and for 48 hours after, re-evaluate renal function before restarting)
• Alcohol (excessive acute or chronic use)

• Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide) - increased risk of lactic acidosis
• Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, isavuconazonium) - increased metformin levels and risk of lactic acidosis

• Diuretics (especially loop diuretics) - may increase risk of lactic acidosis due to potential for renal impairment
• Corticosteroids, sympathomimetics, thyroid products, phenothiazines, niacin, calcium channel blockers, isoniazid - may cause hyperglycemia, requiring metformin dose adjustment
• Sulfonylureas, insulin - increased risk of hypoglycemia (if used concomitantly)

• Not available

• Symptoms of lactic acidosis: malaise, myalgia, respiratory distress, somnolence, abdominal distress, hypothermia, hypotension, bradyarrhythmias.
• Symptoms of hypoglycemia (if used with insulin or sulfonylureas): sweating, tremor, dizziness, confusion, hunger, irritability.
• Gastrointestinal side effects: nausea, vomiting, diarrhea, abdominal discomfort.

Generally considered a preferred oral agent for gestational diabetes or type 2 diabetes in pregnancy when lifestyle modifications are insufficient, especially if insulin is not desired or tolerated. Benefits often outweigh potential risks.

Metformin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding due to low infant exposure and lack of reported adverse effects in breastfed infants.

Metformin ER is not typically approved for pediatric use. Metformin immediate-release (IR) is approved for children 10 years and older for type 2 diabetes.

Use with caution due to increased likelihood of decreased renal function in elderly patients, which increases the risk of lactic acidosis. Renal function should be assessed more frequently. Start with lower doses and titrate slowly.

• Always take Metformin ER with the evening meal to minimize gastrointestinal side effects and optimize absorption.
• Patients may notice a 'ghost tablet' in their stool, which is the inert matrix of the extended-release tablet and is normal.
• Educate patients thoroughly on the symptoms of lactic acidosis and the importance of seeking immediate medical attention if they occur.
• Remind patients to inform all healthcare providers (including dentists and radiologists) that they are taking metformin, especially before any procedures involving iodinated contrast or surgery.
• Consider periodic vitamin B12 monitoring, especially in patients with risk factors for deficiency or those on long-term therapy.

• Sulfonylureas (e.g., Glipizide, Glyburide)
• DPP-4 Inhibitors (e.g., Sitagliptin, Saxagliptin)
• SGLT2 Inhibitors (e.g., Canagliflozin, Dapagliflozin)
• GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide)
• Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone)
• Insulin

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.